A Phase 2 Multicenter, 36-Week Study to Assess the Safety andEffectiveness of Daily Oral Administration of Dexlansoprazole Delayed-Release Capsules for Healing of Erosive Esophagitis and Maintenance ofHealed Erosive Esophagitis and Relief of Heartburn, in Adolescent SubjectsAged 12 to 17 Years
- Conditions
- Heartburn and Erosive Esophagitis in Adolescent SubjectsMedDRA version: 14.1Level: LLTClassification code 10018203Term: GERDSystem Organ Class: 100000004856MedDRA version: 14.1Level: LLTClassification code 10019326Term: HeartburnSystem Organ Class: 100000004856MedDRA version: 14.1Level: LLTClassification code 10063657Term: Erosive esophagitisSystem Organ Class: 100000004856Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2012-001681-15-IT
- Lead Sponsor
- TAKEDA EUROPE RESEARCH & DEVELOPMENT CENTRE LTD
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 62
The subjects must be aged between 12 and 17 years, with a history of symptoms of gastroesophageal reflux disease (GERD) at least 3 months before screening, according to the investigator assessments. To be enrolled in the study, the subject must have heartburn for at least 3 days out of 7 during the screening as logging on daily electronic diary and endoscopically proven EE.
Are the trial subjects under 18? yes
Number of subjects for this age range: 60
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Subjects with an unusual or allergic reaction to dexlansoprazolo or any component of dexlansoprazolo, any of the other proton pump inhibitors (including lansoprazole, omeprazole, rabeprazole, esomeprazole, or pantoprazole), or with antacids containing magnesium hydroxide and / or hydroxide aluminum or simethicone. Individuals with evidence of cardiovascular disease, pulmonary, central nervous system, liver, hematopoietic, renal, metabolic, endocrine or gastrointestinal, or severe allergies, asthma or allergic skin rash that suggests the underlying disease or condition and uncontrolled clinically significant (different from the disease in study), which may affect the subject's ability to participate or could potentially confound the results of the study or any clinically significant discovery resulting from physical examinations and clinical laboratory results, in the opinion of the investigator. Those who need to take prescription drugs or over the counter, which are listed under Drugs & treatments except the Protocol (Section 7.3).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the safety and effectiveness of treatment with once-daily oral administration of dexlansoprazole delayed release capsules 60 mg for 8 weeks in adolescent subjects, aged 12 to 17 years, with EE. To assess the safety and effectiveness of dexlansoprazole delayedrelease capsules 30 mg compared to matching placebo for 16 weeks in adolescent subjects for the maintenance of healed EE and relief of heartburn.;Primary end point(s): 1. Treatment-emergent adverse events experienced by =5% of subjects during the 8-week Treatment Period for healing of Erosive Esophagitis. 2. Treatment-emergent adverse events experienced by =5% of subjects during the 16-week double-blind Treatment Period for maintenance of healed Erosive Esophagitis.;Secondary Objective: NA;Timepoint(s) of evaluation of this end point: 1. Ongoing over the first 8 weeks 2. Ongoing over the 24 week period.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1. The percentage of subjects with healing of Erosive Esophagitis by Week 8 as assessed by endoscopy.2. The percentage of subjects who maintain healing of Erosive Esophagitis from Week 8 to Week 24 among the subjects who were healed at Week 8 as assessed by endoscopy. 3. The percentage of days with neither daytime nor nighttime heartburn over the first 8 weeks of treatment as assessed by electronic daily diary. 4. The percentage of days with neither daytime nor nighttime heartburn over Weeks 8 to 24 as assessed by electronic daily diary among the subjects who were healed at Week 8.;Timepoint(s) of evaluation of this end point: 1. By week 8 2. After 24 weeks 3. Over first 8 weeks 4. Over weeks 8 to 24